The Senior Manager oversees pharmacovigilance activities, including the collection, evaluation, and reporting of adverse drug reactions to ensure regulatory compliance. They lead risk management strategies, signal detection, and the preparation of safety reports while collaborating with clinical and regulatory teams.
Summary
The Senior Manager, Pharmacovigilance reports to the Head of Clinical Development at Gan & Lee Pharmaceuticals USA Corporation or designee. This position is responsible for overseeing pharmacovigilance activities to ensure the safety and compliance of assets under clinical development. The Senior Manager, Pharmacovigilance is accountable for monitoring, detecting, assessing, and reporting adverse drug reactions (ADRs), as well as ensuring effective risk management and regulatory compliance across domestic and international markets. This individual will collaborate with clinical operation teams, regulatory authorities, and other stakeholders to support the safety and continued benefit-risk evaluation of products.
Education and Credentials
Medical degree.
Experience
5-10 years of pharmacovigilance or drug safety experience in the pharmaceutical or biotech industry.
Skills
In-depth knowledge of global pharmacovigilance regulations and drug safety practices, including FDA, EMA, and ICH guidelines.
Strong analytical and problem-solving capabilities, with meticulous attention to detail and the ability to accurately interpret and assess safety data. Proficiency with pharmacovigilance systems and databases (e.g., Argus, ArisGlobal).
Proficiency in data processing software, safety databases, regulatory submission systems, and MedDRA coding.
Skilled in presenting and critically discussing safety data in both internal and external settings.
Experience providing safety inputs for multiple global clinical trials.
Demonstrated ability to manage multiple tasks simultaneously, prioritize effectively, and identify key issues.
Outstanding communication skills, with a proven ability to build and maintain strong relationships with regulatory authorities, internal teams, and external partners.
Responsibilities
Formulate and optimize pharmacovigilance processes and strategy to improve the efficiency and quality of safety assessments and monitoring.
Oversee the collection, evaluation, analysis, and reporting of ADRs, ensuring compliance with global drug safety monitoring standards.
Lead drug safety risk assessments, signal detection activities, and the development and implementation of Risk Management Plans (RMPs), promptly identifying and evaluating potential drug safety risks.
Lead and oversee the management of drug safety data, pharmacovigilance documentation and record, ensuring the accuracy and completeness and confidentiality.
Participate in pharmacovigilance external audits and regulatory inspections, ensuring compliance with all applicable regulations.
Lead the preparation and review of drug safety reports (e.g., PSUR, PBRER, DSUR) to ensure compliance with global regulatory standards. Assist in the preparation of safety narratives and regulatory submissions.
Ensure accurate documentation and archiving of pharmacovigilance data in safety databases. Provide regular drug safety updates to management, regulatory agencies, and partners, ensuring transparency and compliance in pharmacovigilance activities.
Collaborate closely with Clinical, Regulatory Affairs, and other departments to ensure timely and effective communication and sharing of drug safety information.
Provide training to internal teams and external partners on pharmacovigilance processes and requirements.
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